The following data is part of a premarket notification filed by East Health Development Group, Inc. with the FDA for Qi Gong Massager.
| Device ID | K955250 |
| 510k Number | K955250 |
| Device Name: | QI GONG MASSAGER |
| Classification | Vibrator, Therapeutic |
| Applicant | EAST HEALTH DEVELOPMENT GROUP, INC. P.O. BOX 947 Tustin, CA 92680 |
| Contact | Xiaoming Wang |
| Correspondent | Xiaoming Wang EAST HEALTH DEVELOPMENT GROUP, INC. P.O. BOX 947 Tustin, CA 92680 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-02-08 |